Pregnancy and neonatal outcomes of COVID-19: The PAN-COVID study

Objective To assess perinatal outcomes for pregnancies affected by suspected or confirmed SARS-CoV-2 infection. Methods Prospective, web-based registry. Pregnant women were invited to participate if they had suspected or confirmed SARS-CoV-2 infection between 1st January 2020 and 31st March 2021 to assess the impact of infection on maternal and perinatal outcomes including miscarriage, stillbirth, fetal growth restriction, pre-term birth and transmission to the infant. Results Between April 2020 and March 2021, the study recruited 8239 participants who had suspected or confirmed SARs-CoV-2 infection episodes in pregnancy between January 2020 and March 2021. Maternal death affected 14/8197 (0.2%) participants, 176/8187 (2.2%) of participants required ventilatory support. Pre-eclampsia affected 389/8189 (4.8%) participants, eclampsia was reported in 40/ 8024 (0.5%) of all participants. Stillbirth affected 35/8187 (0.4 %) participants. In participants delivering within 2 weeks of delivery 21/2686 (0.8 %) were affected by stillbirth compared with 8/4596 (0.2 %) delivering ≥ 2 weeks after infection (95 % CI 0.3–1.0). SGA affected 744/7696 (9.3 %) of livebirths, FGR affected 360/8175 (4.4 %) of all pregnancies. Pre-term birth occurred in 922/8066 (11.5%), the majority of these were indicated pre-term births, 220/7987 (2.8%) participants experienced spontaneous pre-term births. Early neonatal deaths affected 11/8050 livebirths. Of all neonates, 80/7993 (1.0%) tested positive for SARS-CoV-2. Conclusions Infection was associated with indicated pre-term birth, most commonly for fetal compromise. The overall proportions of women affected by SGA and FGR were not higher than expected, however there was the proportion affected by stillbirth in participants delivering within 2 weeks of infection was significantly higher than those delivering ≥ 2 weeks after infection. We suggest that clinicians’ threshold for delivery should be low if there are concerns with fetal movements or fetal heart rate monitoring in the time around infection

Reducing the Impact of Rheumatoid Arthritis Fatigue: A Randomized Controlled Trial of Cognitive Behavioural Therapy

Background: Up to 90% of people with Rheumatoid Arthritis experience distressing and unmanageable fatigue that impacts profoundly on life. Biological therapies can lessen fatigue but are not always appropriate. In other long-term conditions, fatigue self-management programmes using cognitive behavioural techniques (CBT) have shown benefit. This randomized controlled trial aimed to test CBT in RA fatigue.Methods: CBT was delivered by a clinical psychologist and an occupational therapist in 6 x 2 h weekly group sessions, addressing thoughts, feelings and behaviours and utilized goal setting. Topics included activity cycling (pacing), daily energy expenditure diaries, achieving a balance (prioritizing), stress, communication and assertiveness, sleep and coping with setbacks. The standard information arm (control) comprised a 1 h group session based on the arc fatigue leaflet. Entry criteria were diagnosed RA with a fatigue VAS of ≥ 6/10 and no change in major medication for 4 months (steroids 6 weeks). Assessments: VAS 0-10 for fatigue impact, severity and coping, Multi-dimensional Assessment of Fatigue (MAF 0-50), quality of life (RAQoL 0-30), a sleep quality question (1-4), anxiety and depression (HADS 0-21).Results: 168 patients were randomized. The 127 patients who entered the trial did not differ significantly from the 41 who withdrew before giving baseline data: mean age 59.7 yrs (S.D. 11.3) vs withdrew 56.9 yrs (S.D. 11.7), disease duration 14.5 yrs (S.D. 11.1) vs 14.8 yrs (S.D. 10.4). Of the 41 who withdrew (23 CBT arm, 18 control), slightly more were female (85.4% vs 73.2%). Data were square root transformed where appropriate to achieve normality. Intention-to-treat regression analysis adjusted for baseline scores and group.At baseline, patients in the CBT arm (n = 65) did not differ significantly from controls (n = 62) in any variable. However, at 6 weeks the CBT arm had significantly better scores in every fatigue outcome: fatigue impact in CBT arm mean 5.0 (95% CI 4.2-5.7) vs 6.4 (5.7-7.1), fatigue severity 5.5 (4.8-6.2) vs 6.6 (6.0-7.2), fatigue coping 7.0 (6.3-7.6) vs 5.5 (4.9-6.1) and MAF 27.9 (24.9-30.8) vs 31.4 (28.7-33.9) (all P < 0.001). In addition, all other measures of well-being were significantly better in the CBT group: anxiety CBT 5.5 (4.4-6.9) vs 7.5 (6.1-9.0, p = 0.021), depression 4.7 (3.8-5.7) vs 6.3 (5.3-7.5, P < 0.001), RAQoL 12.9 (11.1-14.7) vs 16.6 (14.6-18.5, P = 0.027) and sleep improvement (41.4% CBT patients vs 21.4%, X2 = 8.1, P = 0.004). Adjustment for age, disease duration or gender had no significant effect on the results.Conclusions: CBT for the self-management of fatigue in RA appears to give substantial short-term benefit to patients for severity and impact of fatigue and perceived ability to cope with fatigue, as well as anxiety, depression and quality of life, compared with provision of self-management information alone. These data suggest an important new avenue of support for people with RA

A randomized trial of endometrial scratching in women with PCOS undergoing ovulation induction cycles

Research question: Does endometrial scratching improve the chance of a live birth in women with polycystic ovary syndrome (PCOS) undergoing ovulation induction and trying to conceive? Design: An international, multicentre, randomized, sham-controlled trial across six fertility clinics in three countries (New Zealand, UK and Brazil). Women with a diagnosis of PCOS who were planning to commence ovulation induction cycles (at least three cycles) in order to conceive were randomly assigned to receive the pipelle (scratch) procedure or a sham (placebo) procedure in the first cycle of ovulation induction. Women kept a diary of ovulation induction and sexual intercourse timing over three consecutive cycles and pregnancies were followed up to live birth. Primary outcome was live birth and secondary outcomes were clinical pregnancy, ongoing pregnancy, multiple pregnancy, adverse pregnancy outcomes, neonatal outcomes, bleeding following procedure and pain score following procedure. Results: A total of 117 women were randomized; 58 to the scratch group and 59 to the sham group. Live birth occurred in 11 (19%) women in the scratch group and 14 (24%) in the sham group (odds ratio 0.76, 95% confidence interval [CI] 0.30–1.92). Secondary outcomes were similar in each group. Significantly higher pain scores were reported in the scratch group (adjusted mean difference 3.2, 95% CI 2.5–3.9) when measured on a visual analogue scale. Conclusion: No difference was detected in live birth rate for women with PCOS who received an endometrial scratch when trying to conceive using ovulation induction; however, uncertainty remains due to the small sample size in this study

Effect of endometrial scratching on unassisted conception for unexplained infertility: a randomized controlled trial

Objective: To investigate whether endometrial scratching increases the chance of live birth in women with unexplained infertility attempting to conceive without assisted reproductive technology. Design: Randomized, placebo-controlled, participant-blind, multicenter international trial. Setting: Fertility clinics. Patient(s): Women with a diagnosis of unexplained infertility trying to conceive without assistance. Intervention(s): Participants were randomly assigned to receive an endometrial biopsy or a placebo procedure (placement of a biopsy catheter in the posterior fornix, without inserting it into the external cervical os). Both groups performed regular unprotected intercourse with the intention of conceiving over three consecutive study cycles. Main Outcome Measure(s): The primary outcome was live birth. Result(s): A total of 220 women underwent randomization. The live birth rate was 9% (10 of 113 women) in the endometrial-scratch group and 7% (7 of 107 women) in the control group (adjusted OR, 1.39; 95% CI, 0.50–4.03). There were no differences between the groups in the secondary outcomes of clinical pregnancy, viable pregnancy, ongoing pregnancy, and miscarriage. Endometrial scratching was associated with a higher pain score on a 10-point scale (adjusted mean difference, 3.07; 95% CI, 2.53–3.60). Conclusion(s): This trial did not find evidence that endometrial scratching improves the live birth rate in women with unexplained infertility trying to conceive without assistance. Clinical Trial Registration Number: Australian New Zealand Clinical Trials Registry ACTRN12614000656639

Thank you to our reviewers

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Thank you to our reviewers

Key Points: The editors thank the 2022 peer reviewer